Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer

NCT00101842 | Completed Phase 1

• 2 other identifiers: 9439H3E-US-S066
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.

Conditions

Carcinoma, Transitional Cell

Outcome Measures

Primary Outcomes (1)

• Toxicity will be measured by standard grading methods.

Secondary Outcomes (5)

• Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).

• Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.

• Time to progressive disease is defined as time from enrollment to first date of disease progression.

• Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment.

• Survival time is defined as time from enrollment to death from any cause.

Interventions

Pemetrexed DRUG

Gemcitabine DRUG

Platinol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven metastatic bladder cancer
• No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment
• Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment
• years of age and older

You may not qualify if:

• Pure adeno- or squamous urothelial cancer
• Brain metastases that causes symptoms
• Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
• Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol
• Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Pemetrexed; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 14, 2005
• First Posted: January 17, 2005
• Study Start: December 1, 2004
• Study Completion: July 1, 2006
• Last Updated: August 29, 2006

Record last verified: 2006-08

Locations

US (1)